Effects Of Extra-fine Particle HFA-becLomethasone (HFA-QVAR) Versus Course Particle Treatment In Smokers and Ex-smokers With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PD20 Adenosine
研究概览
简要总结
We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving small airways dysfunction, especially in ex-smokers and smokers with asthma.
To investigate this, we will perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-smokers and smokers with asthma.
Study design: This study will be an open-label, randomised, three-way cross-over, two-center study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two weeks:
详细描述
Rationale:
Thus far, most clinical studies investigating the effects of inhaled corticosteroids (ICS) in asthma have concentrated on non-smoking asthmatics. However, a considerable proportion of asthma patients smokes. Cigarette smoke consists of ultra-fine particles with a diameter between 0.1 and 1 µm and therefore reaches even the smallest airways. In line with this, it has been reported that smoking is associated with small airways dysfunction. The latter may help to explain the observation that treatment with course particle inhaled corticosteroids is less effective in smokers with asthma. Recently, extra-fine particle aerosols such as hydrofluoroalkane-beclomethasone (HFA-QVAR) have become available for the treatment of asthma, which are more likely to reach the smaller airways. Based on the above, we hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving small airways dysfunction, especially in ex-smokers and smokers with asthma.
Objective: To perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-smokers and smokers with asthma.
Study design:
This study will be an open-label, randomised, three-way cross-over, two-center study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two weeks:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluticasone
Two weeks treatment with HFA-Fluticasone 250 microgram twice daily
干预措施: Beclomethasone (QVAR) (Drug)
Fluticasone
Two weeks treatment with HFA-Fluticasone 250 microgram twice daily
干预措施: Beclomethasone (Clenil) (Drug)
Clenil
Two weeks treatment with HFA-Clenil 200 microgram 2 inhalations twice daily.
干预措施: Beclomethasone (QVAR) (Drug)
Clenil
Two weeks treatment with HFA-Clenil 200 microgram 2 inhalations twice daily.
干预措施: Fluticasone (Drug)
QVAR
Two weeks treatment with QVAR 2 times 100 microgram twice daily
干预措施: Beclomethasone (Clenil) (Drug)
QVAR
Two weeks treatment with QVAR 2 times 100 microgram twice daily
干预措施: Fluticasone (Drug)
结局指标
主要结局
PD20 Adenosine
时间窗: This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone
The primary end-parameter is the PD20 small particle adenosine. The co-primary objective (only in case of non-inferiority of QVAR on the primary objective) will be: Reduction in peripheral airways resistance (R5-R20) measured with IOS at the provocative dose of small particle adenosine causing the FEV1 to drop with 20% (PD20).
次要结局
- Multiple Breath Washout Analysis(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Symptoms and Peakflow(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Airway resistance(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Spirometry(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Body Plethysmography(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Peripheral blood(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Delta FVC during PD20 small particle adenosine.(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Questionnaires(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
- Nasal brushing(This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone)
研究者
Maarten van den Berge
Chest Physician
University Medical Center Groningen